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Jumping Down the Rabbit Hole: Federal Circuit Ducks the Patent-Eligibility Issue in King Pharmaceuticals

As Alice once said things are growing “curioser and curioser.” I just opined about the “fuzzy” looking glass called Bilski v. Kappos for determining what is (or remains) patent-eligible subject matter under 35 U.S.C. § 101. See Through the Fuzzy Bilski Looking Glass: The Meaning of Patent-Eligible under 35 U.S.C. § 101 . After reading King Pharmaceuticals, Inc. v. Eon Labs, Inc., I’m now ready to throw my Ouija board though that Bilski looking glass. With an opportunity to render some order out of the Bilski chaos, the Federal Circuit instead completely ducked the patent-eligibility issue clearly presented in King Pharmaceuticals. The Federal Circuit then created (and I do mean “created”) the new “an anticipated method claim doesn’t become patentable if it simply includes an informing step about an inherent property of that method” doctrine. With this new “doctrine,” we have now “jumped down the rabbit hole” into a surreal “Bilski in Patentland” world.

The King Pharmaceuticals case starts off innocently enough with an appeal from a district court decision invalidating four claims under 35 U.S.C. § 101, three claims under 35 U.S.C. § 103, and the remaining claims under 35 U.S.C. § 102 from U.S. Pat. No. 6,407, 128 (the ‘128 patent) and U.S. Pat. No. 6,683,102 (the ‘102 patent) on a motion for summary judgment. What became the focus of the subsequent bizarre ruling by the Federal Circuit was dependent method claim 21 of the ‘128 patent.

Claim 21 depended directly from method claim 1 of the ’128 patent. Claim 1 recited “a method of increasing the oral bioavailability of metaxalone” (in the preamble) by “administering to the patient a therapeutically effective amount of metaxalone in a pharmaceutical composition with food.” Claim 21 recited the additional feature of “informing” the patient that taking that metaxalone with food would increase the bioavailability of the metaxalone.

The district court found that claim 1 of the ‘128 patent was inherently anticipated under 35 U.S.C. § 102 by prior art showing that taking metaxalone with food was already known and that all the ‘128 patent disclosed/claimed was an inherent property (i.e., increased bioavailability from taking metaxalone with food) of this known method. In other words, what claim 1 recited was recognition of a new benefit of what was essentially an old “method of use.” Accordingly, the Federal Circuit quite correctly affirmed the district court’s ruling that the method of claim 1 was on the basis that “merely discovering and claiming a new benefit of an old process cannot render the process again patentable” (citing the 1990 Federal Circuit case of In re Woodruff).

Where Judge Gajarsa’s opinion in King Pharmaceuticals “jumps down the rabbit hole” is the handling of dependent claim 21. The district court invalidated claim 21 under 35 U.S.C. § 101, citing the Federal Circuit’s en banc ruling in Bilski which foisted on us the unfortunate “machine or transformation” (MoT) only test. With SCOTUS having deemed that MoT was no longer the exclusive test for patent-eligibility under 35 U.S.C. § 101, claim 21 in King Pharmaceuticals presented the Federal Circuit with a perfect opportunity to inform us “mere mortals” what SCOTUS’ “fuzzy” ruling in Bilski really means in the context of methods such as those defined in claim 21.

Gajarsa’s opinion was obviously troubled by how to treat the “informing” feature in claim 21. In response to the patentee’s (King Pharmaceutical’s) contention that the district court incorrectly dissected claim 21 to separate out this “informing” feature, Gajarsa’s opinion pointed to SCOTUS’ Parker v. Flook decision that the analysis of patent-eligibility under 35 U.S.C. § 101 should be based on the claim “as a whole.” In fact, Gajarsa’s opinion observed that, prior to SCOTUS’s decision in Bilski, the Federal Circuit had “held that such medical treatment methods were patentable processes under [35 U.S.C. § 101 because they fell squarely within” the MoT test, referring the 2009 case of Prometheus Laboratories, Inc. v. Mayo Collaborative Services. So far so good.

Unfortunately, Gajarsa’s opinion then turned “white rabbit” and jumped down the hole into Bilski in Patentland: “The present case, however, does not present the proper vehicle for determining whether claims covering medical treatment methods are eligible for patenting under [35 U.S.C] § 101 because even if claim 21 recites patent eligible subject matter, that subject matter is anticipated for the reasons discussed below.” So what were those “reasons?” Initially, Gajarsa’s opinion stated that “we are not limited to a district court’s stated reasons for invalidating claims and can affirm a grant of summary judgment on any ground supported by the record and adequately raised below.” Already, “red warning flags” were going off in my head that Gajarsa’s opinion was about to head off into new territory in Patentland.

King Pharmaceuticals pointed out that the district court never found that the “informing” feature of claim 21 was disclosed in the prior art. But Gajarsa’s opinion brushed that objection aside by saying the “informing” feature “adds no novelty to the method, which is otherwise anticipated by the prior art.” Accordingly, because claim 1 was anticipated, “it readily follows that claim 21, which recites the same method with the sole additional step of informing the patient about this increase in bioavailability, is not patentable.” Voila, we have the new doctrine of “features which are not patentable cannot breathe novelty into an otherwise anticipated method.”

Gajarsa’s opinion tries to bolster support for this new doctrine by analogy to the “printed matter is not patentable” doctrine from the 1983 case of In re Gulack, and the more recent 2004 case of In re Ngai. I particularly cringe at the citation to the Ngai case. In Ngai, the patent applicant had created an admittedly new method for amplifying and normalizing RNA. In addition to method claims, the patent applicant included what many of us patent attorneys/agents referred to as “kit claims” which recited “instructions for use” where those instructions described the new method (in Ngai, the method for amplifying and normalizing RNA). The Federal Circuit in Ngai rejected those “kit claims” as either anticipated under 35 U.S.C. § 102 or unpatentable under 35 U.S.C. § 103 (isn’t clear which basis the Federal Circuit relied upon) under the “printed matter is not patentable doctrine.” What particularly offends me about the Federal Circuit’s reliance on the “printed matter is not patentable doctrine” in Ngai is the following statement: “If we were to adopt Ngai’s position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.” So what? The logic of that statement for supporting the invalidity of “kit claims” in Ngai as anticipated/obvious still escapes me.

In my view, the handling by Gajarsa’s opinion of the patent-eligibility issue with regard to claim 21 is as bizarre as the strained effort by Judge Lourie to shoe-horn the drug dosage calibration method of Prometheus into the “transformative” prong of the MoT test. See CAFC: Method for Calibrating Drug Dosage Is Transformative . Garjasa and company obviously found the patent-eligibility issue squarely raised in King Pharmaceuticals troublesome to deal with, but how they resolved the invalidity of claim 21 (“informing” feature about inherent property of method doesn’t make an otherwise anticipated method patentable) is as illogical as Justice Stevens saying in Parker v. Flook that an otherwise unknown algorithm is prior art under 35 U.S.C. § 103. The Federal Circuit needs to address the patent-eligibility issue of claimed methods/processes such as those presented in King Pharmaceuticals forthrightly and logically (and sooner rather than later) before we “mere mortals” are forced to jump down the rabbit hole after them into the chaotic Bilski in Patentland world.

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Discuss this

There are currently 10 Comments comments.

SkepticalAugust 4, 2010 7:52 am

““If we were to adopt Ngai’s position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.” So what? ”

Would a response as simple as “But I don’t infringe because I don’t include that piece of paper with those words on it” suffice to clear any potential infringers (not all elements) of those pernicious indefinite patents?

EGAugust 4, 2010 9:09 am

Skeptical,

Under the hypothetical you state, it would avoid direct infringement. I definitely subscribe to the All Elements/All Limitations Rule for both literal, as well as DOE, infringement. (BTW, I don’t view “kit claims” like those in Ngai to be either “pernicious” or “indefinite.”)

Why patentees resort to “kit claims” with “instructions for use” is because of the problems with asserting direct infringement of “method of use” patents. Usually, the direct infringer is the customer who practices the patented method, not the supplier of the drug; the supplier has to be pursued under a contributory or inducing infringement theory which can be messy to prove, especially if the supplier is outside the U.S.

Thanks for the comment.

IANAEAugust 4, 2010 9:36 am

Usually, the direct infringer is the customer who practices the patented method, not the supplier of the drug;

Isn’t that an inherent disadvantage of patenting a new use for an existing product? You shouldn’t be able to stop people selling the product, since the product itself is prior art. The only people actually infringing are the ones who are using the old product in the new way. It’s unfortunate that you can’t sue the deep pockets, but that’s not really what the patent system is all about. It’s about going after the actual infringers.

My problem with basing patentability on new printed matter in this particular case is that the printed matter is a statement of inherent fact about the product, and the product is identical to the prior art product. From what I recall, there isn’t even a claim to a novel and non-obvious dosage level. If the discovery of the new inherent property of the prior art drug is not patentable, why should it become so by the addition of “hey, look what I discovered!” on the package? And it literally is that in this case. It’s not even an instruction to use the drug in a new way, because it was already well known to take that drug with food. All it does is prevent market competitors from indicating on their prior art product an inherent feature of that product that is probably the result of a scientific study they would otherwise be free (and eager) to cite.

Remember when all those french fry and potato chip manufacturers started marking their products as “cholesterol-free”? It turns out all fries and chips are inherently cholesterol-free. Wouldn’t it have been silly to grant to the first company a patent on consuming prior art potato chips as art of a reduced-cholesterol diet, and let them be the only ones to advertise this fact about their (and everybody’s) product?

This seems to me a clear-cut case of anticipation, and the Circuit probably dodged the 101 issue to appeal-proof it.

EGAugust 4, 2010 9:56 am

“My problem with basing patentability on new printed matter in this particular case is that the printed matter is a statement of inherent fact about the product, and the product is identical to the prior art product. From what I recall, there isn’t even a claim to a novel and non-obvious dosage level. If the discovery of the new inherent property of the prior art drug is not patentable, why should it become so by the addition of “hey, look what I discovered!” on the package? ”

IANAE,

Let me be clear that I’m not saying that claim 21 of the ‘128 patent was patentable. It’s hard to believe that “informing” the patient of this bioavailability isn’t taught somewhere (and if it isn’t, we’ve got another problem).

By contrast, in Ngai, the method described in the instructions for use was deemed to be separately novel and unobvious. If that’s true, then how can a “kit” combined with “instructions for use” describing that patentable method (be it deemed “printed matter” or not) be deemed anticipated/obvious? Again, what the Federal Circuit said and did in Ngai is as illogical as Justice Stevens saying that unknown algorithms nonetheless “prior art” under 35 USC 103.

My frustration in this case is with this Federal Circuit panel creating a new “doctrine” which treats the requirements of 35 USC 102/103 as essentially superfluous. As they say “bad facts make bad law” and this new “doctrine” is likely to come back to haunt the Federal Circuit, as well as us “mere mortals.” Judge Newman is particularly critical (and rightly so) whenever the Federal Circuit simply treats the language the patent statutes as if they don’t exist. You can’t have consistent, logical precedent that treats the patent statutes this way (and SCOTUS is by far the greatest offender in this regard).

Anyway, thanks for the comment.

IANAEAugust 4, 2010 10:17 am

It’s hard to believe that “informing” the patient of this bioavailability isn’t taught somewhere

That’s the discovery underlying the purported invention, isn’t it? Surely the increased bioavailability wasn’t known in the art, and a fortiori neither was informing people of it.

By contrast, in Ngai, the method described in the instructions for use was deemed to be separately novel and unobvious. If that’s true, then how can a “kit” combined with “instructions for use” describing that patentable method (be it deemed “printed matter” or not) be deemed anticipated/obvious?

If the kit contains a new combination of parts, for example, it might be claimable even without the instructions. That’s more analogous to claiming a lower dosage of a drug because of the newly-discovered increased bioavailability. In that case, the instructions are your smoking gun for contributory infringement if you have a claim to the instructed method. If the kit is an old combination of parts with new instructions, you again come dangerously close to preventing manufacturers of a lawful product (the prior art kit) from accurately describing an inherent use of their product.

What’s the new doctrine here? The doctrine that writing stuff on a prior art product doesn’t make it patentable is old. Telling people to use an old product in an infringing way is precisely what inducement is intended to capture, so it doesn’t bother me as a matter of principle that the courts won’t let applicants capture the same activity as direct infringement. Sure, it’s frustrating that you get fewer people to sue, but that’s because you invented something that only the end-user can infringe.

The evergreening problem is not new either. It’s the reason we have the judicially-created (lest we forget) doctrine of obviousness-type double patenting. If you want another patent with another 20-year term, you need to go invent something else.

And believe me, I feel your pain about the missed opportunity to clarify 101. But really there’s no reason for the Circuit to tread on unsteady ground when the 102 case seems solid. There are plenty of 101 cases still in the pipeline, and ones with better facts. I don’t think kit claims (or the claims in this case) run afoul of 101 anyway.

New HereAugust 4, 2010 10:18 am

In general, I find the SCOTUS did well with the Bilski case, as seen now a flood of interpretation on it has created an apparent scramble to hold on to the old pre-Bliski patent system. Challenges will continue for patents post-Bilski, because the responsibility for them, will not want to be shared by those that may look as if they “slipped-up”. Mistakes for “innovation” now means an embarrassing return to the SCOTUS and the Federal Circuit is and will not be alone in taking a growing degree of caution, placing a great deal of attention on what passes !

The **patent everything** idea has a problem now, it must make decisions without a map, about the direction to take to the PTO with success. The SCOTUS, have left no path to just follow as well, as most of that has been covered up. Interpretation of others means little to those that will take the responsibility for failure to preventing contradiction with the SCOTUS’s language, failure that provides evidence that the patent system is unable to guide itself that would harm the United States world wide. No one wants the responsibility all in their hands and *you* can’t always fight that !

step backAugust 4, 2010 12:07 pm

From my vantage point, the court is incapable of thinking outside the patent law box.

This is not a 101 issue.

This a First Amendment issue.

Does the claim seek to preclude free speech?

(free speech about an inherent process)

Paul F. MorganAugust 4, 2010 12:51 pm

I agree with several commentors here and elsewhere that a 103 obviousness ruling would have been much easier and better. (i.e., not creating a new legal doctrine).
Just because a decision below is based on 102 is no reason why the Federal Circuit cannot sustain it on 103 instead, when the only missing claim element in the cited prior art was clearly obvious and does not make the claim as a whole unobvious. Especially since, as this and other decisions have held, an appelate court can affirm correct decisions even if based on incorrect legal theories. But is not this particular kind of case further confused by the legal principle that the discovery of an inherent property of a known compound is not patentable, even if that discovery was unobvious, hence merely communicating that property orally or otherwise by obvious means falls with it?

IANAEAugust 4, 2010 12:59 pm

Does the claim seek to preclude free speech?

Does the First Amendment entitle you to shout “higher bioavailability” in a crowded art?

scrappyAugust 5, 2010 8:43 pm

Historically, prior art products and methods have been deemed by the courts to include all inherent features and steps, whether those features and steps were known.

It would follow then that telling someone about an included feature or step is/would have been obvious.

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